Evaluation of KGR Prescriptions in Suppressing COVID-19 Infection.

NCT06291883 | Completed Phase 1

• 1 other identifier: CHUH112-REC2-008
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

These studies offer valuable insights into the potential development of KGR as a novel herbal-based preventive and therapeutic strategy against COVID-19.

Conditions

Coronavirus Disease 2019; Severe Acute Respiratory Syndrome Coronavirus 2 Infection

Keywords

coronavirus disease 2019; severe acute respiratory syndrome coronavirus 2; Kang Guan Recipe; variants of concern; angiotensin-converting enzyme 2

Outcome Measures

Primary Outcomes (1)

• Serum Infection rate of pseudocells

  Collected Blood, centrifuge to obtain serum samples. Each serum sample were diluted and premixed with wild-type or different variants of SARS-CoV-2 spike Vpps for one hours before incubation with 293T-ACE2 cells. After 24 hours of infection, the infection efficiency rate was measured according to luciferase activities.

  Before taking, 2 hours after taking, and 2 hours after taking 24 hours later.

Study Arms (2)

Treat

EXPERIMENTAL

four packets of concentrated powder per day.

Combination Product: Kang Guan Recipe (Treat)

Control

PLACEBO COMPARATOR

four packets of concentrated powder per day.

Combination Product: Kang Guan Recipe (Placebo)

Interventions

Kang Guan Recipe (Treat) COMBINATION_PRODUCT

Accurately weigh the Chinese medicinal herbs in the formula by weight, conduct the origin identification of the medicinal materials, and follow the scientific traditional Chinese medicine preparation process. After extraction, concentration, and granulation, package them in aluminum foil, with each package containing 6 grams of concentrated powder.

Treat

Kang Guan Recipe (Placebo) COMBINATION_PRODUCT

Use 3% Kang Guan Recipe concentrated powder, mix evenly with starch, and package in aluminum foil, with each package containing 6 grams of concentrated powder.

Control

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy participants aged 20-60 with a body weight of over 50 kilograms.
• Individuals who have never been diagnosed with COVID-19 or have recovered from COVID-19 for more than three months.
• No consumption of any traditional Chinese medicine or food containing Chinese medicine within the preceding 36 hours before the experiment.
• Vaccinated individuals who received their vaccine more than three months ago.
• Willingness to undergo venous blood tests (approximately 10 cc of blood to be drawn three times).

You may not qualify if:

• History of major internal medical conditions, including diabetes, hypertension, chronic obstructive pulmonary disease (COPD), asthma, abnormal liver function (AST levels exceeding 5 times the normal value), renal dysfunction (eGFR \<60), cancer, etc.
• Brain disorders such as trauma, stroke, tumors, epilepsy, or dementia.
• Mental health disorders such as depression, anorexia nervosa, or schizophrenia.
• Pregnant or lactating women. If there is suspicion of pregnancy, a commercial urine pregnancy test will be conducted.
• Smokers, alcoholics, or betel nut addicts.
• Inability to comply with the trial procedures.
• Inability to sign the informed consent form.
• Within three months of a confirmed COVID-19 diagnosis.
• Within three months of receiving a vaccine shot.

Sponsors & Collaborators

• Sheng-Teng Huang: lead

Study Sites (1)

China Medical University Hospital

Taichung, North District, 404, Taiwan

Location

MeSH Terms

Conditions

COVID-19

Interventions

Coal Tar

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Tars; Complex Mixtures

Study Officials

• Sheng-Teng Huang, MD PhD

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 4, 2024
• Study Start: February 9, 2023
• Primary Completion: April 18, 2023
• Study Completion: February 8, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03

Locations

TW (1)